CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) (PS-010)

September 17, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Nebraska
      • Omaha, Nebraska, United States, 63198-7835
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center and the New York Presbyterian Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.

For inclusion in the study subjects must fulfill ALL of the following criteria:

Pre-EPS inclusion criteria:

  1. Patients with a clinical history of AVNRT who are referred for ablation.
  2. Patients willing to provide written informed consent.

Post-EPS inclusion criteria:

1. Patients with EPS-documented AVNRT

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

  1. Patients with any pre-existing AV block.
  2. Patients with known cryoglobulinemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Freezor Catheter for AVNRT
Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Other Names:
  • 7F Freezor Cardiac CryoAblation Catheter
OTHER: External Data Supporting the Study
This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System
cryoablation
Other Names:
  • 7F Freezor Cardiac CryoAblation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
Time Frame: After 250 subjects have been enrolled.
After 250 subjects have been enrolled.

Secondary Outcome Measures

Outcome Measure
Time Frame
AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.
Time Frame: After 250 subjects have been enrolled.
After 250 subjects have been enrolled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: John Lehmann, MD, MPH, Lehmann Consulting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (ESTIMATE)

February 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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